The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Once daily for four weeks
Unnamed facility
Tokyo, Japan
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined.
Time frame: Day 1
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Time frame: Day 7
Pharmacokinetic: Cmax of Betamethasone Dipropionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone dipropionate was determined
Time frame: Day 14
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Time frame: Day 1
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Time frame: Day 7
Pharmacokinetic: AUClast of Betamethasone Dipropionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone dipropionate was determined
Time frame: Day 14
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax(Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Time frame: Day 7
Pharmacokinetic: Cmax of Betamethasone 17-propionate
The mean Cmax (Maximum Observed Plasma Concentration) of betamethasone 17- propionate was determined
Time frame: Day 14
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Time frame: Day 1
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Time frame: Day 7
Pharmacokinetic: AUClast of Betamethasone 17-propionate
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for betamethasone 17-propionate was determined
Time frame: Day 14
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Time frame: Day 1
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Time frame: Day 7
Pharmacokinetic: Cmax of Calcipotriol
The mean Cmax (Maximum Observed Plasma Concentration) of calcipotriol was determined
Time frame: Day 14
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Time frame: Day 1
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Time frame: Day 7
Pharmacokinetic: AUClast of Calcipotriol
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for calcipotriol was determined
Time frame: Day 14
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Time frame: Day 1
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Time frame: Day 7
Pharmacokinetic: Cmax of MC1080
The mean Cmax (Maximum Observed Plasma Concentration) of MC1080 was determined
Time frame: Day 14
Pharmacokinetic: AUClast of MC1080
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Time frame: Day 1
Pharmacokinetic: AUClast of MC1080.
To assess the The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Time frame: Day 7
Pharmacokinetic: AUClast of MC1080.
The mean AUClast (Area under the Plasma Concentration-Time Curve from Time 0 to the Last Observed Measurable Concentration) for MC 1080 was determined
Time frame: Day 14
Efficacy: Percentage Change in m-PASI From Baseline to Day 28
Psoriasis Area and Severity Index (PASI) is based on the investigator's assessment of the disease. The extent and severity of redness, thickness and scaliness of psoriasis are recorded for three regions (arms, trunk and legs) and these are used to calculate PASI. The PASI can range between 0 (best) to 64.8 (worst). m-PASI indicate that the scale is modified.
Time frame: Baseline to Day 28
Efficacy: Subjects With 'Clear' or 'Almost Clear' Disease by Investigator's Global Assessment at Day 28.
Subjects with 'clear' or 'almost clear' disease by investigator's globala ssessment at day 28. Investigator global assessment (IGA) is based on the investigator's assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear,Almost clear, Mild,Moderate, Severe, and Very severe). The assessment represents the average lesion severity on the trunk and limbs. IGA can range between 1 (best) and 6 (worst). The assessment is based on the condition of the disease at the time of evaluation, and not in relation to the condition at a previous visit.
Time frame: Day 28